Adalimumab-aaty Receives Interchangeability Designation

The FDA has granted interchangeability designation to adalimumab-aaty, or Yuflyma (Celltrion) including its prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations, for all the same indications as reference adalimumab (Humira), including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (PsO), hidradenitis suppurativa (HS), and uveitis (UV) in adult patients; Crohn's disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older.1

"This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape," Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, said in a statement.1 "YUFLYMA – a high-concentration, citrate-free adalimumab biosimilar now fully interchangeable with Humira – reflects our long-standing commitment to delivering high-quality, accessible treatment options. Going forward, Celltrion will continue to put patients first by keeping drug costs affordable and remaining at the forefront of the U.S. biosimilar market, bringing competitive pricing and high-quality, accessible treatment options."

The interchangeable designation was based off of the Phase III interchangeability study, which demonstrated similar pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque PsO who received reference adalimumab continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Weeks 25-27. The full data from the interchangeability study were presented at the European Academy of Dermatology & Venereology (EADV) in the Netherlands in September 2024.

Adalimumab-aaty first entered the United States market in July 2023 and is currently available as a 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg in autoinjectors. The biosimilar is available in both branded and unbranded versions at 2 pricing options.

Other recent research supported adalimumab biosimilar interchangeability and the practice of non-medical switches between such biosimilars for patients with psoriasis, with the most commonly registered treatment discontinuation reason being a loss of effect.2

Among all of the study cohorts, it was reported that therapy discontinuation took place within 6 months after the switch ranged from 0% - 8.2%. The highest rate of discontinuiation that the investigative team observed took place following the initial switch from the originator to GP2017.2

They added that the lowest rate had been seen following the third switch in the originator cohort, specifically from ABP 501 to GP2017. Among the reasons given for cessation, the loss of therapeutic effect was the most commonly reported one. The investigators highlighted that 2 subjects stopped treatment as a result of adverse events, though subsequent remission was attained upon resuming the originator biologic.2

REFERENCES

1. Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths. News release. Celltrion. May 23, 2025. https://www.prnewswire.com/news-releases/celltrions-yuflyma-adalimumab-aaty-receives-fda-interchangeability-designation-for-all-its-approved-dosage-forms-and-strengths-302464475.html

2. Krogh-Jensen O, Schwarz CW, Kaur-Knudsen D, et al (2025). Real-world experience of multiple switches between adalimumab biosimilars in patients with psoriasis. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.20727.